Kroger Cetirizine Hydrochloride Tablets USP, 10 mg
- Manufacturer
- Kroger Company | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2025-09-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:13:32
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Cetirizine HCl 10 mg
OTC - PURPOSE SECTION
Antihistamine
INDICATIONS & USAGE SECTION
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
WARNINGS SECTION
Warnings
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
OTC - WHEN USING SECTION
When using this product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
OTC - STOP USE SECTION
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
(1-800-222-1222).
DOSAGE & ADMINISTRATION SECTION
Directions
adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over: ask a doctor
children under 6 years of age: ask a doctor
consumers with liver or kidney disease: ask a doctor
OTHER INFORMATION
Other information
- store between 20° to 25°C (68°to 77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? 1-800-632-6900
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CETIRIZINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41226-692-14 | ALLERGY | 70 in 1 BOTTLE | TABLET, FILM COATED | 70 | 5 | |
| 41226-692-14 | ALLERGY | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 5 | |
| 41226-692-65 | ALLERGY | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 41226-692-65 | ALLERGY | 365 in 1 BOTTLE | TABLET, FILM COATED | 365 | 5 | |
| 41226-692-70 | ALLERGY | 70 in 1 BOTTLE | TABLET, FILM COATED | 70 | 5 | |
| 41226-692-70 | ALLERGY | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 |
Products#
Every source-derived product name is available through these pages.
- ALLERGY
- CETIRIZINE HYDROCHLORIDE
- STARCH, CORN
- LACTOSE MONOHYDRATE
- POVIDONE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- HYPROMELLOSES
- MAGNESIUM STEARATE
- TITANIUM DIOXIDE
- CETIRIZINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41226-692 | 41226-692-65, 41226-692-14, 41226-692-70 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| POVIDONE | FZ989GH94E | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078933-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2010-06-15 | ||
| A078933-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2010-06-15 | ||
| A078933-003 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2010-06-15 | ||
| A078933-004 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2010-06-15 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078933-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-06-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078933-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-06-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078933-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2010-06-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078933-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2010-06-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078933-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-06-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078933-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-06-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078933-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2010-06-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078933-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2010-06-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078933-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-06-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078933-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-06-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078933-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2010-06-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078933-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2010-06-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078933-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-06-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078933-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-06-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078933-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2010-06-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078933-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2010-06-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078933-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-06-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078933-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-06-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078933-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2010-06-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078933-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2010-06-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078933-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-06-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078933-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-06-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078933-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2010-06-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078933-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2010-06-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078933-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-06-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078933-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-06-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078933-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2010-06-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078933-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2010-06-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078933-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-06-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078933-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-06-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078933-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2010-06-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078933-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2010-06-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078933-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-06-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078933-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-06-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078933-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2010-06-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078933-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2010-06-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078933-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-06-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078933-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-06-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078933-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2010-06-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078933-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2010-06-15 | d8e5a09893c0… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ALLERGY | CETIRIZINE HYDROCHLORIDE | Kroger Company | bc020340-ef39-e49a-e053-2a95a90af810 | 2025-09-11 | Warnings | 41226-692-14 41226-692-70 41226-692-65 41226-692 41226069214 41226069270 41226069265 3e7fad54-62e1-6d0a-e063-6394a90a5785 bc020340-ef39-e49a-e053-2a95a90af810 |





